Montmed, Inc., a company dedicated to bridging the gap between science and behavior in diabetes care to deliver better outcomes while reducing the cognitive burden associated with living with diabetes, today announced that the United States Patent and Trademark Office (USPTO) has issued a second US Patent 11,517,659, adding to the company’s novel technology patent family which aims at helping insulin users to easily and seamlessly develop and implement healthy injection site rotation practices.

Insulin users inject themselves anywhere from 1 to 6 or more times daily. This daily repeated administration of exogenous insulin, a growth hormone, combined with the repeated trauma of needle micro-injury, leads to a serious complication called lipohypertrophy. Lipohypertrophy, which is defined as an abnormal accumulation of fat underneath the surface of the skin, is present in up to 64% of insulin users and leads to sub-optimal insulin absorption2. Studies have shown that the lack of injection site rotation is the largest risk factor in developing lipohypertrophy2. Lipohypertrophy has been shown to have important repercussions on glycemic control, such as an elevation in HbA1C, increased glucose variability, increased unexplained hypoglycemia as well as an increase in insulin requirements of up to 22%1. Therefore, in addition to its proven clinical benefits, ensuring insulin users adopt a healthy injection site rotation may also reduce the economic burden of insulin use. Currently, there is no simple and intuitive way to help health care professionals teach, and patients adhere to a structured site rotation routine. As a result, injection site rotation is not broadly adopted resulting in more than half of insulin users using one site only to inject their insulin4.

Montmed has developed the Sitesmart™, a novel pen needle system designed to favor the teaching and adherence to a healthy injection site rotation regimen. Each package of Sitesmart contains 100 insulin pen needles distinctively marked with 4 colors, along with educational messages and an association tool labeled directly on the packaging that allows the user to simply and easily create a personalized structured injection site rotation plan, in which each of the four colors of pen needle is associated with a distinct injection area, seamlessly instructing the insulin user where to inject at each injection.

Positive clinical data from a randomized controlled trial were published in October 2020, which demonstrated that the sole dispensing of Sitesmart pen needles system by a retail pharmacist was an impactful, low tech and scalable intervention that resulted in a significant improvement in injection site rotation. The study showed Sitesmart delivered a 134.7% increase in the likelihood to improve site rotation over conventional pen needles, without adding any cost to the health care system. It was also hypothesized that the distinctive nature of the Sitesmart pen needle system may also act as a reminder for insulin users to change their pen needles after use, and therefore, reduce needle re-use, in accordance with clinical recommendations. The study demonstrated that, in addition to ensuring healthy injection site rotation, needle re-use was reduced by 25% in Sitesmart users.

Montmed’s initial patent specifically covers distinctively marked injection devices, including insulin pen needles, in combination with a user-defined association tool that allows the user to create and implement a personalized injection site rotation plan, and thus reduce the risk of developing lipohypertrophy. The newly issued patent 11,517,659 adds to the initial patent by integrating the concept of distinctive marks and user-defined association in a digital device or software.

Amir Farzam, chief executive officer of Montmed, commented, “We are extremely pleased that the USPTO has once again recognized our innovation. The issuance of this new US patent, paired with our positive clinical data and the successful proof of concept in the Canadian market is paving the way for us to bring our innovation to insulin users in the US. We remain committed to transforming the utility of an insulin pen needle from a simple insulin delivery device to a clinically valuable tool that can improve health outcomes and reduce costs by helping insulin users seamlessly integrate healthy injection site rotation into their daily routine, and importantly, at no additional direct cost to the healthcare system. To this effect, we are initiating our 510k process in Q1 2023”.